Trial Outcomes & Findings for Dysvascular Amputation Self-Management of Health (NCT NCT04083456)
NCT ID: NCT04083456
Last Updated: 2026-08-13
Results Overview
The number of steps per day measured with ActivPAL, assessed for 10 days at 3 months and 6 months. 10-day average at 3 months and at 6 months reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
3 months and 6 months
Results posted on
2026-08-13
Participant Flow
Participant milestones
| Measure |
Walking Biobehavioral Intervention (EXP)
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Walking Biobehavioral Intervention (EXP)
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
missed visit
|
1
|
0
|
Baseline Characteristics
Dysvascular Amputation Self-Management of Health
Baseline characteristics by cohort
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
Walking Biobehavioral Intervention: Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
Attention Control: Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=1 Participants
|
14 Participants
n=1 Participants
|
31 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=1 Participants
|
15 Participants
n=1 Participants
|
30 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=1 Participants
|
14 Participants
n=1 Participants
|
27 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
African-American
|
4 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
multiracial
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
|
Amputation level
transtibial
|
15 Participants
n=1 Participants
|
14 Participants
n=1 Participants
|
29 Participants
n=1 Participants
|
|
Amputation level
transfemoral or knee disarticulation
|
3 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 9 • n=1 Participants
|
66 years
STANDARD_DEVIATION 8 • n=1 Participants
|
65 years
STANDARD_DEVIATION 8 • n=1 Participants
|
|
Daily step count
|
905 steps per day
STANDARD_DEVIATION 1105 • n=1 Participants
|
1237 steps per day
STANDARD_DEVIATION 1095 • n=1 Participants
|
1066 steps per day
STANDARD_DEVIATION 1099 • n=1 Participants
|
PRIMARY outcome
Timeframe: 3 months and 6 monthsPopulation: Persons with complete data;
The number of steps per day measured with ActivPAL, assessed for 10 days at 3 months and 6 months. 10-day average at 3 months and at 6 months reported.
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=15 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=16 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Physical Activity
3-month
|
1646 steps per day
Standard Deviation 1791
|
1531 steps per day
Standard Deviation 1145
|
|
Physical Activity
6 months
|
2157 steps per day
Standard Deviation 2090
|
1782 steps per day
Standard Deviation 1457
|
SECONDARY outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Measures participant's confidence in managing symptoms of chronic disease. Higher scores indicate greater confidence in symptom management. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale.
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms
baseline
|
0.1 theta score
Standard Deviation 0.7
|
-0.2 theta score
Standard Deviation 0.8
|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms
Month 3
|
0.1 theta score
Standard Deviation 0.9
|
0.2 theta score
Standard Deviation 0.9
|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms
Month 6
|
-0.01 theta score
Standard Deviation 0.8
|
-0.1 theta score
Standard Deviation 0.8
|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms
Month 12
|
-0.5 theta score
Standard Deviation 1.0
|
0.1 theta score
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Measures participant's confidence in managing daily activities. Higher scores indicate greater confidence in managing daily activities. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale.
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities
Baseline
|
-0.6 theta score
Standard Deviation 0.6
|
-0.6 theta score
Standard Deviation 0.7
|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities
Month 3
|
-0.4 theta score
Standard Deviation 0.9
|
-0.2 theta score
Standard Deviation 0.8
|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities
Month 6
|
-0.4 theta score
Standard Deviation 0.8
|
-0.4 theta score
Standard Deviation 0.8
|
|
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities
Month 12
|
-0.7 theta score
Standard Deviation 1.0
|
-0.2 theta score
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Measures participant's ability to participate in social roles and activities. Higher scores indicate more ability to participate. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale."
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
Baseline
|
-0.4 theta score
Standard Deviation 1.0
|
-0.7 theta score
Standard Deviation 0.6
|
|
Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
Month 3
|
-0.5 theta score
Standard Deviation 1.1
|
-0.4 theta score
Standard Deviation 0.8
|
|
Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
Month 6
|
-0.2 theta score
Standard Deviation 0.9
|
-0.3 theta score
Standard Deviation 0.8
|
|
Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
Month 12
|
-0.7 theta score
Standard Deviation 1.1
|
-0.3 theta score
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: Lost to follow-up
Self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility)
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Prosthesis Evaluation Questionnaire - Mobility Score
Baseline
|
2.0 PEQ-MS Score
Standard Deviation 1.3
|
2.0 PEQ-MS Score
Standard Deviation 1.0
|
|
Prosthesis Evaluation Questionnaire - Mobility Score
Month 6
|
2.4 PEQ-MS Score
Standard Deviation 0.7
|
2.6 PEQ-MS Score
Standard Deviation 0.8
|
|
Prosthesis Evaluation Questionnaire - Mobility Score
Month 3
|
2.5 PEQ-MS Score
Standard Deviation 1.0
|
2.4 PEQ-MS Score
Standard Deviation 0.9
|
|
Prosthesis Evaluation Questionnaire - Mobility Score
Month 12
|
2.2 PEQ-MS Score
Standard Deviation 1.3
|
2.5 PEQ-MS Score
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair.
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Timed Up-and-Go Test
Baseline
|
35 seconds
Standard Deviation 19
|
37 seconds
Standard Deviation 23
|
|
Timed Up-and-Go Test
Month 6
|
24 seconds
Standard Deviation 13
|
19 seconds
Standard Deviation 10
|
|
Timed Up-and-Go Test
Month 3
|
28 seconds
Standard Deviation 14
|
23 seconds
Standard Deviation 14
|
|
Timed Up-and-Go Test
Month 12
|
18 seconds
Standard Deviation 13
|
15 seconds
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Self-reported disability. Final scores range from 0 (no disability) to 100 (full disability).
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
World Health Organization-Disability Assessment Schedule 2.0
Month 12
|
17.6 WHODAS score
Standard Deviation 12.1
|
14.2 WHODAS score
Standard Deviation 10.2
|
|
World Health Organization-Disability Assessment Schedule 2.0
Month 3
|
14.4 WHODAS score
Standard Deviation 10.2
|
15.1 WHODAS score
Standard Deviation 9.2
|
|
World Health Organization-Disability Assessment Schedule 2.0
Baseline
|
15.1 WHODAS score
Standard Deviation 8.1
|
16.5 WHODAS score
Standard Deviation 7.4
|
|
World Health Organization-Disability Assessment Schedule 2.0
Month 6
|
13.6 WHODAS score
Standard Deviation 6.3
|
15.9 WHODAS score
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Self-reported confidence in managing different aspects of chronic disease. Final scores range from 1 (not at all confident in managing chronic disease) to 10 (totally confident in managing chronic disease).
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Self-Efficacy for Managing Chronic Disease
Baseline
|
7.9 SEMCD score
Standard Deviation 2.1
|
7 SEMCD score
Standard Deviation 1.6
|
|
Self-Efficacy for Managing Chronic Disease
Month 6
|
6.9 SEMCD score
Standard Deviation 2.3
|
7.5 SEMCD score
Standard Deviation 2.5
|
|
Self-Efficacy for Managing Chronic Disease
Month 3
|
7.0 SEMCD score
Standard Deviation 2.4
|
7.3 SEMCD score
Standard Deviation 2.2
|
|
Self-Efficacy for Managing Chronic Disease
Month 12
|
5.8 SEMCD score
Standard Deviation 3.0
|
7.0 SEMCD score
Standard Deviation 2.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Self-reported balance confidence. Final scores range from 0% (no confidence in balance) to 100% (complete confidence in balance).
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=17 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Activities-specific Balance Confidence Scale
Baseline
|
55.0 ABC score
Standard Deviation 29.6
|
53.1 ABC score
Standard Deviation 24.0
|
|
Activities-specific Balance Confidence Scale
Month 6
|
69.2 ABC score
Standard Deviation 19.8
|
64.2 ABC score
Standard Deviation 25.6
|
|
Activities-specific Balance Confidence Scale
Month 3
|
59.1 ABC score
Standard Deviation 24.9
|
61.1 ABC score
Standard Deviation 28.4
|
|
Activities-specific Balance Confidence Scale
Month 12
|
56.2 ABC score
Standard Deviation 32.5
|
63.3 ABC score
Standard Deviation 29.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Distance a participant can walk in two minutes. Use of assistive device is noted
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=16 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Two-Minute Walk Test
Baseline
|
214 meters
Standard Deviation 127
|
187 meters
Standard Deviation 76
|
|
Two-Minute Walk Test
Month 6
|
283 meters
Standard Deviation 132.5
|
279 meters
Standard Deviation 101.3
|
|
Two-Minute Walk Test
Month 3
|
214 meters
Standard Deviation 98
|
246 meters
Standard Deviation 90
|
|
Two-Minute Walk Test
Month 12
|
328 meters
Standard Deviation 156
|
327 meters
Standard Deviation 83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, 3 months, 6 months and 12 monthsPopulation: lost to follow-up
Evaluates gait speed and functional mobility. The participant walks 5 meters, at a comfortable walking pace. Higher speed indicates better mobility.
Outcome measures
| Measure |
Walking Biobehavioral Intervention (EXP)
n=17 Participants
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
|
Attention Control (CTL)
n=17 Participants
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
|
|---|---|---|
|
Five Meter Walk
Month 6
|
7.4 meters per second
Standard Deviation 3.7
|
6.6 meters per second
Standard Deviation 1.9
|
|
Five Meter Walk
Month 3
|
9.7 meters per second
Standard Deviation 4.5
|
7.8 meters per second
Standard Deviation 4.1
|
|
Five Meter Walk
Month 12
|
7.7 meters per second
Standard Deviation 5.5
|
5.6 meters per second
Standard Deviation 1.2
|
|
Five Meter Walk
Baseline
|
13.5 meters per second
Standard Deviation 11
|
12.3 meters per second
Standard Deviation 6.1
|
Adverse Events
Walking Biobehavioral Intervention (EXP)
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Attention Control (CTL)
Serious events: 8 serious events
Other events: 13 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 participants at risk
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
Walking Biobehavioral Intervention: Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.
|
Attention Control (CTL)
n=17 participants at risk
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
Attention Control: Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.
|
|---|---|---|
|
Infections and infestations
Wound infection
|
16.7%
3/18 • Number of events 3 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Infections and infestations - Other
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
2/18 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis lower limb
|
11.1%
2/18 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Psychiatric disorders
Hallucinations
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Lymphedema
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Vascular disorders - Other
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
2/18 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
Other adverse events
| Measure |
Walking Biobehavioral Intervention (EXP)
n=18 participants at risk
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
Walking Biobehavioral Intervention: Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.
|
Attention Control (CTL)
n=17 participants at risk
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
Attention Control: Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
2/18 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
23.5%
4/17 • Number of events 4 • from enrollment until end of follow-up, up to 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
22.2%
4/18 • Number of events 6 • from enrollment until end of follow-up, up to 12 months
|
23.5%
4/17 • Number of events 5 • from enrollment until end of follow-up, up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
11.1%
2/18 • Number of events 3 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Eye disorders
Retinopathy
|
5.6%
1/18 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Eye disorders
Vitreous hemorrhage
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
General disorders
Edema limbs
|
11.1%
2/18 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Infections and infestations
Infections and infestations - Other
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
11.8%
2/17 • Number of events 3 • from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
61.1%
11/18 • Number of events 19 • from enrollment until end of follow-up, up to 12 months
|
47.1%
8/17 • Number of events 17 • from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • from enrollment until end of follow-up, up to 12 months
|
5.9%
1/17 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
0.00%
0/17 • from enrollment until end of follow-up, up to 12 months
|
Additional Information
Cory Christiansen
University of Colorado Anschutz Medical Campus
Phone: 303-724-9101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place